A novel technique predicting velopharyngeal insufficiency risk in newborns following primary cleft repair. A randomized clinical trial comparing buccinator flap and Bardach two-flap palatoplasty

Oro-nasal communication, suckling difficulty, recurrent respiratory tract infection and later problematic swallowing and mastication are complications of the palatal gaps encountered in infants with cleft palate. Moreover, abnormal speech and hearing patterns that develop as they grow grossly affect their communication and merging with society, with subsequent reduction in their chances in education and working environment. McQueen KA et al., 2009, Kara M et al., 2020; Yuanyuan et al., 2021.

Bardach two-flap palatoplasty relies on the greater palatine artery as the main blood supply. The initial technique of Bardach was suitable for the repair of narrow clefts only; however, by the modification of the technique through creating more releasing incisions and dissection, closure of wide clefts was attained with high success rate (Bardach J, 1995; Leow AM & Lo LJ, 2008; Mir MA et al., 2021).

However, the main drawback of the Bardach technique is that it does not add length to the palatal tissues, thus increasing the risk of developing velopharyngeal insufficiency (VPI) postoperatively with subsequent speech problems (Bardach J et al., 1982; Bae YC et al., 2002; Salyer et al., 2006).

The velopharyngeal mechanism results from the function of group of muscles that create velopharyngeal sphincter (soft palate, post pharyngeal wall and lateral pharyngeal walls). The muscles that are compromised in cleft palate patients include the levtor veli palatini, tensor veli palatini and musclus uvulae. The proper repair of these muscle is critical in restoring and optimizing the function of the velopharyngeal sphincter (Chauhan JS et al., 2020 & Kara M et al., 2021). A properly constructed muscle with proper muscle length that approaches the posterior and lateral pharyngeal walls during the action of sphincter is significant in creating the necessary oral pressure for certain consonants. Moreover, the degree of pharyngeal depth has also been correlated with the risk of postoperative VPI (Liu C et al., 2022). VPI has been assessed in an older age group (age 2.5-3 years) directly by video nasopharyngeal endoscopy, multiview speech video fluoroscopy or both (functional method) (Chauhan JS et al., 2020). Short palatal length is one of the risk factors for developing VPI (McComb RW et al., 2011; Vale F et al., 2022).

For the previously mentioned reasons, this study aimed to predict the VPI via palatal length measurement (anatomical method/indirect technique) in a younger age group (age 1-1.5 years) following primary cleft repair by 2 different palatoplasty techniques.

Palatal fistula is defined as direct communication between the oral and nasal cavity through an opening anywhere from the incisive foramen to the uvula resulting from breakdown of the cleft palate repair flap (de Agostino Biella Passos V et al., 2014; Gilardino Mirko S et al., 2018).

Symptomatic palatal fistula is usually associated with hypernasality, less ability to pronounce consonants due to air escapement during pronunciation, and nasal regurgitation of fluids and food during eating. However, other fistulas may be totally asymptomatic (Bekerecioglu M et al., 2005).

Palatal fistula has a rate in the range from 3% to 45% and may present in multiple forms ranging from tiny fistula undetected by direct vision, pinpoint fistula, small or moderate, rounded or oval classic shape fistula to total wound dehiscence (Schendel SA et al., 1999; Bresnick S et al., 2003).

The buccinator myomucosal flap (BMF), being anatomically myomucosal (ie, formed of two layers: mucosal layer and muscle layer), makes BMF ideal for reconstruction of the soft palate due to the great similarity of the type of mucosa. The buccal mucosa is non-keratinized stratified squamous epithelium as in the soft palate. Moreover, both the BMF and soft palate contain muscle, mucous salivary gland and fat cells. The increased thickness and rich blood supply of the flap are the main advantages (Joshi A et al., 2005; Ferrari S et al., 2012; Diogo Diogo Franco et al., 2014).

Bhayani evaluated the use of BMF in primary and secondary repairs of cleft palate in 160 operations from 1999 to 2011 (Bhayani B, 2014). The results showed that the fistulation rate was 4.8% in primary palatoplasty and 8.3% in secondary repairs. Speech assessment for infants who had undergone primary palatoplasty with BMF showed good results. For infants with secondary repairs with BMF, for whom the aim was to repair fistulation or to increase the length of the soft palate to overcome VPI, there was improvement in speech and a decrease in hypernasality. Six months following primary repair with the buccinator flap, speech assessment identified 72% of patients with normal speech pattern, 4% with mild speech compromise and 12% with moderate compromise. The authors reported that using BMF in primary and secondary repairs offers anatomical and functional repair, especially in wide clefts (Bhayani B, 2014).

The risk of wound dehiscence and fistulation is higher in wider than in narrower clefts because of the deficiency in the amount of available soft tissue for repair. Transfer of vascularized soft tissue to overcome the inherited deficiency in the amount and quality of soft tissue at cleft site improves the results and decreases the scarring potential and long-term complications such as mid face hypoplasia and shortening of the soft palate (due to scarring) and subsequent development of VPI. Beside the use of different types of flaps in primary cleft palate repair, fat grafting has also been used in either primary or secondary repairs, owing to its abundancy and rich blood supply (Haas OL Jr. et al., 2023).

Primary repair of the cleft palate with BMF is a relatively simple, easy and safe procedure to be performed (Jackson IT et al., 2004).

To the best of our knowledge, there is no study that has compared the fistulation rate between these two flaps. Thus, the present study was designed to evaluate the use of buccinator flap in primary repair of cleft palate to decrease the fistulation rate and to predict the risk of development of VPI following primary palatoplasty in palatal cleft newborns.

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